Back to resultsHypertrophic Scar Prevention by Novel Topical Gel Application
Primary Purpose
Hypertrophic Scar
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pentamidine Isethionate
Silicone Gels
Sponsored by
About this trial
This is an interventional prevention trial for Hypertrophic Scar
Eligibility Criteria
Inclusion Criteria:
-• Diagnosis of hypertrophic scar by board-certified plastic surgeon or dermatologist at Mayo Clinic.
- Target disease or condition: Hypertrophic scar
Subject with a hypertrophic scar that meet all of the following criteria:
- Linear scar ≥5 to ≤40 cm in length
- Present for minimum 6 months
- Located anywhere in the body except on the face or front of neck
- Resulting from surgical or traumatic injury
- Ability to safely undergo scar excision surgery
- Capacity to provide informed consent
- Ability to comply with protocol
- Subject is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, electrocardiogram, vital signs, and clinical laboratory tests.
Exclusion Criteria:
- Subjects identified as having keloid or burn scars
- Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody and HIV as determined in screening the subject's Electronic Medical Record.
- Concurrent use of corticosteroids (including inhaled steroids), cyclooxygenase-2 (COX-2) inhibitors and/or drugs that are strong inhibitors and inducers of cytochrome P450 (CYP) enzymes
- Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
- Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study.
- Subjects with renal and hepatic impairment.
- Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation.
- Any infection or wound in the area to treat including photosensitive dermatosis or inflammatory acne.
- Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug
- Participation in another clinical study in the past 30 days or concurrent participation in another clinical trial.
- Patients with poorly controlled diabetes mellitus (HbA1C ≥ 8%), peripheral neuropathy, or known concomitant vascular problems.
- Pregnant or lactating female patients.
- Prisoners.
- Subjects who smoke cigarettes and/or use other tobacco products.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Topical agent A
Topical agent B
Arm Description
Topical Pentamidine Isethionate will be randomized to be applied to either the proximal or distal end of the incision. The patient is his/her own control.
Silicone Gels base will be randomized to be applied either to the proximal or distal end of the incision. The patient is his/her own control
Outcomes
Primary Outcome Measures
Serious and non-serious adverse events
Adverse events include skin infection, skin irritation and wound dehiscence. Skin irritation is scored by local skin reaction (LSR) grading scale. Wound infection is defined by skin that is red, swollen, hot and painful ("calor, dolor, rubor, tumor") [by clinical exam] with or without discharge. Wound dehiscence is defined as a measurable breaking open of the surgical incision along the suture. Serious adverse events are defined as death [due to treatment] or life threatening adverse experience [due to treatment], hospitalization [due to treatment], persistent or significant disability or incapacity [due to treatment], birth defect/anomalies [due to treatment] and tissue necrosis [due to treatment].
Secondary Outcome Measures
Serious and non-serious adverse events
Adverse events include skin infection, skin irritation and wound dehiscence. Skin irritation is scored by local skin reaction (LSR) grading scale. Wound infection is defined by skin that is red, swollen, hot and painful ("calor, dolor, rubor, tumor") [by clinical exam] with or without discharge. Wound dehiscence is defined as a measurable breaking open of the surgical incision along the suture. Serious adverse events are defined as death [due to treatment] or life threatening adverse experience [due to treatment], hospitalization [due to treatment], persistent or significant disability or incapacity [due to treatment], birth defect/anomalies [due to treatment] and tissue necrosis [due to treatment].
Scar volume
Ultrasound will be used to quantify hypertrophic scar dimensions (length, width and height) and volume size using cm3 as the unit of measure.
Scar histology
Semi-quantitative assessment of skin fibrosis will be done using the following variables and semi-quantitative scoring: Epidermal hyperplasia/hyperkeratosis, presence of hair follicles, presence of apocrine glands, presence of smooth muscles, presence of fibroplasia, presence of vascular proliferation (each 0,1), collagen orientation (0-3).
Vancouver Scar Scale (VSS)
The VSS assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. Scale ranges are as follows. Pigmentation (0=normal, 1=hypopigmentation, 2=hyperpigmentation). Height (0=flat, 1=less than 2 mm, 2=2 to 5 mm, 3=greater than 5 mm). Vascularity (0=normal, 1=pink, 2=red, 3=purple). Pliability (0=normal, 1=supple, 2=yielding, 3=firm, 4=banding,5=contracture). Total score can range from 0 to 13, with 0=normal skin, and 13=severe scarring.
Patient and Observer Scar Assessment Scale (abbreviated: POSAS)
POSAS consists of 2 scales: the observer scale assesses vascularity, pigmentation, thickness, relief, pliability, and surface area; the patient scale assesses pain, itching, color, stiffness, thickness, and irregularity. The scales rate each variable on a scale from 1 (normal skin) to 10 (worst scar imaginable), with a total possible score ranging from 1 (normal) to 120 (worst scar imaginable).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03403621
Brief Title
Hypertrophic Scar Prevention by Novel Topical Gel Application
Official Title
Double Blind, Single-Center, Randomized, Within Subject Placebo, Phase I Study Evaluating the Effects of Novel Topical Gel in Prevention of Hypertrophic Scar Formation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Funding changes.
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Researchers are trying to find out more about the side effects of topical (applied to the skin) Pentamidine, to determine if it is safe for use in people. They also want to find out if topical use of Pentamidine can help treat hypertrophic scars.
Pentamidine is a medicine that is currently used to treat certain kinds of infection. It is most often given by intravenous (into a vein) or inhalation (through a breathing device). This medication is approved by the U.S. Food and Drug Administration (FDA) for use in these forms.
Everyone in this study will receive topical Pentamidine (TP) in a silicone based gel (PCCA Pracasil Plus). Topical treatment of Pentamidine is still experimental and has not been formally tested for safety or effectiveness in a randomized control trial within the United States. The FDA has allowed the use of topical Pentamidine in this research study.
Detailed Description
This study will investigate Pentamidine isethionate, compounded in a silicone-containing base, as adjuvant therapy to surgical scar excision to prevent adverse scarring and enhance skin rejuvenation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All participants will receive two treatments: drug and vehicle. Drug will be applied to one of two treatment sites. Vehicle will be applied to the other site. Treatment sites are distal and proximal end of the incision. Drug will be randomized to treatment site "distal" or "proximal" and masking will be as indicated. A 1-2 cm border zone will remain untreated in the middle of the scar.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Randomization will done by the Research Pharmacy
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical agent A
Arm Type
Experimental
Arm Description
Topical Pentamidine Isethionate will be randomized to be applied to either the proximal or distal end of the incision. The patient is his/her own control.
Arm Title
Topical agent B
Arm Type
Placebo Comparator
Arm Description
Silicone Gels base will be randomized to be applied either to the proximal or distal end of the incision. The patient is his/her own control
Intervention Type
Drug
Intervention Name(s)
Pentamidine Isethionate
Other Intervention Name(s)
Topical Pentamidine
Intervention Description
Pentamidine isethionate prepared in a silicone base will be applied topically
Intervention Type
Drug
Intervention Name(s)
Silicone Gels
Other Intervention Name(s)
PCCA Pracasil Plus (PP)
Intervention Description
Silicone base will be applied topically
Primary Outcome Measure Information:
Title
Serious and non-serious adverse events
Description
Adverse events include skin infection, skin irritation and wound dehiscence. Skin irritation is scored by local skin reaction (LSR) grading scale. Wound infection is defined by skin that is red, swollen, hot and painful ("calor, dolor, rubor, tumor") [by clinical exam] with or without discharge. Wound dehiscence is defined as a measurable breaking open of the surgical incision along the suture. Serious adverse events are defined as death [due to treatment] or life threatening adverse experience [due to treatment], hospitalization [due to treatment], persistent or significant disability or incapacity [due to treatment], birth defect/anomalies [due to treatment] and tissue necrosis [due to treatment].
Time Frame
4 weeks post-operatively
Secondary Outcome Measure Information:
Title
Serious and non-serious adverse events
Description
Adverse events include skin infection, skin irritation and wound dehiscence. Skin irritation is scored by local skin reaction (LSR) grading scale. Wound infection is defined by skin that is red, swollen, hot and painful ("calor, dolor, rubor, tumor") [by clinical exam] with or without discharge. Wound dehiscence is defined as a measurable breaking open of the surgical incision along the suture. Serious adverse events are defined as death [due to treatment] or life threatening adverse experience [due to treatment], hospitalization [due to treatment], persistent or significant disability or incapacity [due to treatment], birth defect/anomalies [due to treatment] and tissue necrosis [due to treatment].
Time Frame
Weeks 1,2,3 and 4 post-operatively
Title
Scar volume
Description
Ultrasound will be used to quantify hypertrophic scar dimensions (length, width and height) and volume size using cm3 as the unit of measure.
Time Frame
US will be done at baseline (pre-operatively) and at postop week 2 and 4.
Title
Scar histology
Description
Semi-quantitative assessment of skin fibrosis will be done using the following variables and semi-quantitative scoring: Epidermal hyperplasia/hyperkeratosis, presence of hair follicles, presence of apocrine glands, presence of smooth muscles, presence of fibroplasia, presence of vascular proliferation (each 0,1), collagen orientation (0-3).
Time Frame
Skin punch biopsy will be done at baseline (preoperatively) and again at postop week 2 and 4.
Title
Vancouver Scar Scale (VSS)
Description
The VSS assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. Scale ranges are as follows. Pigmentation (0=normal, 1=hypopigmentation, 2=hyperpigmentation). Height (0=flat, 1=less than 2 mm, 2=2 to 5 mm, 3=greater than 5 mm). Vascularity (0=normal, 1=pink, 2=red, 3=purple). Pliability (0=normal, 1=supple, 2=yielding, 3=firm, 4=banding,5=contracture). Total score can range from 0 to 13, with 0=normal skin, and 13=severe scarring.
Time Frame
VSS will be completed by the patient and care provider at baseline (preoperatively) and at weeks 2and 4.
Title
Patient and Observer Scar Assessment Scale (abbreviated: POSAS)
Description
POSAS consists of 2 scales: the observer scale assesses vascularity, pigmentation, thickness, relief, pliability, and surface area; the patient scale assesses pain, itching, color, stiffness, thickness, and irregularity. The scales rate each variable on a scale from 1 (normal skin) to 10 (worst scar imaginable), with a total possible score ranging from 1 (normal) to 120 (worst scar imaginable).
Time Frame
POSAS will be completed by the patient and care provider at baseline (preoperatively) and at weeks 2 and 4.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-• Diagnosis of hypertrophic scar by board-certified plastic surgeon or dermatologist at Mayo Clinic.
Target disease or condition: Hypertrophic scar
Subject with a hypertrophic scar that meet all of the following criteria:
Linear scar ≥5 to ≤40 cm in length
Present for minimum 6 months
Located anywhere in the body except on the face or front of neck
Resulting from surgical or traumatic injury
Ability to safely undergo scar excision surgery
Capacity to provide informed consent
Ability to comply with protocol
Subject is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, electrocardiogram, vital signs, and clinical laboratory tests.
Exclusion Criteria:
Subjects identified as having keloid or burn scars
Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody and HIV as determined in screening the subject's Electronic Medical Record.
Concurrent use of corticosteroids (including inhaled steroids), cyclooxygenase-2 (COX-2) inhibitors and/or drugs that are strong inhibitors and inducers of cytochrome P450 (CYP) enzymes
Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study.
Subjects with renal and hepatic impairment.
Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation.
Any infection or wound in the area to treat including photosensitive dermatosis or inflammatory acne.
Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug
Participation in another clinical study in the past 30 days or concurrent participation in another clinical trial.
Patients with poorly controlled diabetes mellitus (HbA1C ≥ 8%), peripheral neuropathy, or known concomitant vascular problems.
Pregnant or lactating female patients.
Prisoners.
Subjects who smoke cigarettes and/or use other tobacco products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Meves, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Hypertrophic Scar Prevention by Novel Topical Gel Application
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